The Breakfast Study

StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Results posted: Oct 19, 2026 Show 6 more changesShow less
    • Primary endpoints: 1 to 2
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints revised (11)
    • Study description revised
    • Collaborators expanded, about 10 words
    • Publications: details revised at 1 of 1 entry
  2. Phase: Phase 1/2 to Not applicable
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: 5 to 11
    • Study description shortened, about 3 words
    v7
  3. Secondary endpoints: 6 to 5v6
  4. Primary endpoint revisedv5 Show 5 more changesShow less
    • Trial status: Active, Not Recruiting to Completed
    • Enrollment target: estimated 120 to confirmed 119
    • Primary completion date changed from estimate of Oct 31, 2025 to Oct 9, 2025
    • Study completion date changed from estimate of Oct 31, 2025 to Oct 17, 2025
    • Secondary endpoints: 8 to 6
  5. Trial status: Recruiting to Active, Not Recruiting
    • Primary and study completion dates: Oct 15, 2025 to Oct 31, 2025
    • Site details revised
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Eligibility criteria revised
    • Study description revised
    v3
  2. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
University of Michigan
374 trials monitored
See 22 trials at risk
Diabetes
5,101 trials monitored
See 233 trials at risk
Type 2 Diabetes
2,236 trials monitored
See 113 trials at risk
The investigators conducted an acceptability, feasibility, preliminary effectiveness trial of a 4-month, online, very low-carbohydrate breakfast-focused program in 120 adults with type 2 diabetes. The investigators measured acceptability and feasibility, plus critical efficacy outcomes, such as changes in HbA1c, anti-hyperglycemic medications, glycemic variability, body weight, blood pressure, and lipids.
Trial Details
NCT Number NCT05986097
Lead Sponsor University of Michigan
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions
(from sponsor)		 Type 2 Diabetes
Related terms Diabetes Mellitus, Type 2
Enrollment 119 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov